Major Depressive DisorderPhase 1NCT01924520
Oral Multiple-dose Study in Patients With Major Depressive Disorder
A Phase 1 study testing FK949E in people with Major Depressive Disorder, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- FK949E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesJapan
- Study dates
- Nov 2010to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR
- Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study.
- Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator.
Who cannot join
- A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to provision of written informed consent.
- Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status.
- A history of substance or alcohol abuse or dependence excluding caffeine and nicotine.
- Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to screening assessment and throughout the study period.
- Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier).
- Patients being treated for hypertension or patients with clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina).
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- Patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmHg)
- Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)
- A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma).
- A history of transient ischemic attack (TIA).
- A history of seizure disorder, except for febrile convulsions
- Application of electroconvulsive therapy within 90 days prior to the start of study drug administration
- Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to screening assessment and throughout the study period
- A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months. Patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder
A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).
Read the detailed description
The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).
- Conditions
- Major Depressive Disorder
- Being tested
- FK949E
- Keywords
- Antipsychotic, FK949E, Quetiapine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK949EDrug
Also called extended-release formulation of quetiapine
Oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (FK949E lower dose) | Experimental | Oral Receives: Drug: FK949E |
| Group 2 (FK949E middle dose) | Experimental | Oral Receives: Drug: FK949E |
| Group 3 (FK949E higher dose) | Experimental | Oral Receives: Drug: FK949E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of unchanged quetiapine
Measured: for 24 hours after dosing
AUC24h (area under the curve for 24hr) of unchanged quetiapine
Measured: for 24 hours after dosing
Secondary outcomes (8)
trough value of plasma concentration of unchanged quetiapine
Measured: for 24 hours after dosing
t1/2 of plasma concentration of unchanged quetiapine
Measured: for 24 hours after dosing
Maximum plasma concentration (Cmax) of quetiapine metabolites
Measured: for 24 hours after dosing
AUC (area under the curve) of quetiapine metabolites
Measured: for 24 hours after dosing
trough value of plasma concentration of quetiapine metabolites
Measured: for 24 hours after dosing
tmax of plasma concentration of quetiapine metabolites
Measured: for 24 hours after dosing
t1/2 of plasma concentration of quetiapine metabolites
Measured: for 24 hours after dosing
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924520
- Sponsor's protocol ID
- 6949-CL-0009
- Status last verified
- Feb 2017
- First submitted
- 14 Aug 2013
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01924520
- Acronym / sponsor ID
- 6949-CL-0009
- Conditions
- Major Depressive Disorder
- Keywords
- Antipsychotic, FK949E, Quetiapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).
Detailed description
The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (FK949E lower dose) | Experimental | Drug: FK949EOral |
| Group 2 (FK949E middle dose) | Experimental | Drug: FK949EOral |
| Group 3 (FK949E higher dose) | Experimental | Drug: FK949EOral |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR
- Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study.
- Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator.
Key exclusion criteria (14 listed)
- A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to provision of written informed consent.
- Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status.
- A history of substance or alcohol abuse or dependence excluding caffeine and nicotine.
- Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to screening assessment and throughout the study period.
- Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FK949EAlso: extended-release formulation of quetiapineOral | Drug | Group 1 (FK949E lower dose), Group 2 (FK949E middle dose), Group 3 (FK949E higher dose) |
Primary outcome
Maximum plasma concentration (Cmax) of unchanged quetiapine
Time frame: for 24 hours after dosing
AUC24h (area under the curve for 24hr) of unchanged quetiapine
Time frame: for 24 hours after dosing
8 secondary outcomes
trough value of plasma concentration of unchanged quetiapine
Time frame: for 24 hours after dosing
t1/2 of plasma concentration of unchanged quetiapine
Time frame: for 24 hours after dosing
Maximum plasma concentration (Cmax) of quetiapine metabolites
Time frame: for 24 hours after dosing
AUC (area under the curve) of quetiapine metabolites
Time frame: for 24 hours after dosing
trough value of plasma concentration of quetiapine metabolites
Time frame: for 24 hours after dosing
tmax of plasma concentration of quetiapine metabolites
Time frame: for 24 hours after dosing
t1/2 of plasma concentration of quetiapine metabolites
Time frame: for 24 hours after dosing
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
Time frame: Up to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FK949E in people with Major Depressive Disorder, run by Astellas Pharma Inc at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of unchanged quetiapine (time frame: for 24 hours after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017; AzTrials last refreshed its copy on 5 Nov 2026.